Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005746
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Community Site Coronary Risk Control in Black Families
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To test the effectiveness of a community site neighborhood health workernurse NHWN case management strategy for coronary heart disease risk reduction compared with usual care in apparently healthy African American siblings of persons with documented premature coronary heart disease
Detailed Description:
BACKGROUND
The rationale for this program proceeded from the markedly increased risk of initial coronary events in siblings with coronary artery disease with onset before age 50 There is an excess of treatable coronary heart disease risk factors in such siblings and a high prevalence of adult atherosclerosis
DESIGN NARRATIVE
The study recruited 364 siblings of individuals with early coronary disease Eligible subjects were randomized to community-based care CBC or enhanced primary care EPC with a community health site neighborhood health workernurse for 1 year follow up Intervention participants were stratified based on results of treadmill testing to either more or less aggressive management of their lipids according to National Cholesterol Education Program guidelines All positive participants on the exercise stress test were directly referred to their physicians Diabetics were referred to their primary physician for treatment Intervention in the intervention group was carried out on traditional coronary heart disease CHD risk factors including diet physical activity blood pressure LDL cholesterol and cigarette smoking The intervention built on a prior sibling study in Blacks and whites
The approach was that rather than carrying out the intervention at the central John Hopkins Clinic thus requiring transportation of potentially anxious participants to a strange environment the new interventions were carried out by trained local NHWs in a more accessible local community site The nutrition interventions used fat counters that focused on total fat gram goals and intervention was carried out by the NHWN with assistance from cookbooks appropriate for African American households Siblings were requested to come monthly for dietary counseling Smoking cessation interventions used individual counseling previously carried out by the investigators Smoking assessment included self-report and measures of carbon monoxide CO in expired air Study physicians carried out pharmacologic interventions for blood pressure lipids and lipoproteins Diabetes treatment was through referral to the patients private physician Nurses provided oversight to NHWs
Neighborhood health workers were trained and certified in taking blood pressure BP phlebotomy and CO measurements at the Center for Health Promotion at Johns Hopkins which had an NHW training program for blood pressure Outcomes measures included changes in blood pressure smoking behavior and plasma concentrations of lipids and lipoproteins Attention was paid to potential modifying factors such as demographic factors eg education socioeconomic status income occupation
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
The rationale for this program proceeded from the markedly increased risk of initial coronary events in siblings with coronary artery disease with onset before age 50 There is an excess of treatable coronary heart disease risk factors in such siblings and a high prevalence of adult atherosclerosis
DESIGN NARRATIVE
The study recruited 364 siblings of individuals with early coronary disease Eligible subjects were randomized to community-based care CBC or enhanced primary care EPC with a community health site neighborhood health workernurse for 1 year follow up Intervention participants were stratified based on results of treadmill testing to either more or less aggressive management of their lipids according to National Cholesterol Education Program guidelines All positive participants on the exercise stress test were directly referred to their physicians Diabetics were referred to their primary physician for treatment Intervention in the intervention group was carried out on traditional coronary heart disease CHD risk factors including diet physical activity blood pressure LDL cholesterol and cigarette smoking The intervention built on a prior sibling study in Blacks and whites
The approach was that rather than carrying out the intervention at the central John Hopkins Clinic thus requiring transportation of potentially anxious participants to a strange environment the new interventions were carried out by trained local NHWs in a more accessible local community site The nutrition interventions used fat counters that focused on total fat gram goals and intervention was carried out by the NHWN with assistance from cookbooks appropriate for African American households Siblings were requested to come monthly for dietary counseling Smoking cessation interventions used individual counseling previously carried out by the investigators Smoking assessment included self-report and measures of carbon monoxide CO in expired air Study physicians carried out pharmacologic interventions for blood pressure lipids and lipoproteins Diabetes treatment was through referral to the patients private physician Nurses provided oversight to NHWs
Neighborhood health workers were trained and certified in taking blood pressure BP phlebotomy and CO measurements at the Center for Health Promotion at Johns Hopkins which had an NHW training program for blood pressure Outcomes measures included changes in blood pressure smoking behavior and plasma concentrations of lipids and lipoproteins Attention was paid to potential modifying factors such as demographic factors eg education socioeconomic status income occupation
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL058625 | NIH | None | httpsreporternihgovquickSearchR01HL058625 |